Our client, a medical device engineering company based in Limerick who specialize in manufacturing precision components are seeking a Senior Quality Engineer to join their team.
Responsibilities include but are not limited to:
* Specification development, CTQ mapping, test method development and validation, process validations and implementation of CCP within the process, using error proofing, process monitoring, SPC.
* Complaint handling, NC management, Risk and Impact assessment, CAPA, Root cause investigation and solution development and verification and Change control.
* Supplier Quality Management.
* Product release.
* Product test and release planning, change management and audit.
* Critical thinking and technical writing.
* Quality lead on multi/cross functional teams to achieve milestones and results.
* Represents the company in Customer interactions relating to product process and system quality elements in a professional, constructive, and commercially aware manner.
* Ensures that customer product requirements are defined and implemented within the site QMS
* Engage with the new product development team to ensure a smooth transition from development to production.
* Identify and implement continuous improvements across the board and takes initiatives to make things better every day.
* Owns and drives the Safety/Quality/Service/Cost Metric for the VS.
* Minimum Level 8 Qualification.
* Minimum of 5 years of direct QMS experience
* Validation experience, MSA experience and Gauge R&R experience
* On the job training will be provided for the right candidate.
* Strong written and oral communication skills.
* Experience working with medical device regulations is desirable.
* Good computer skills in usage of MS Office Suite
* Working knowledge of EN ISO 13485, FDA QSR 21 CFR Part 820 and principles of GMP in the Medical Device Industry.
Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies.
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